Effect of MOF on Exercise Blood Pressure

Healthy Clinical Trial

Official title:

Effect of Monomeric and Oligomeric Flavanols on Exercise Blood Pressure and Vascular Function in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907097
• Other study ID #: NL77344.068.21
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Maastricht University Medical Center
• Contact: Khrystyna O. Semen, MD, PhD
• Phone: +31630412370
• Email: k.semen[@]ymaastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish an effect of monomeric and oligomeric flavanols supplementation on exercise blood pressure and vascular function in healthy volunteers.

Description:

Exaggerated exercise blood pressure (BP) response in healthy subjects is recognized as a risk factor of hypertension and cardiovascular events. Pathogenetically exaggerated BP response is attributed to compromised vascular(endothelial) functions as well as oxidative stress and inflammation. Monomeric and oligomeric flavanols (MOF) are dietary components with well-characterized beneficial effects on the redox homeostasis, endothelial function and microvascular health. The objectives of the study will be to evaluate the effects of MOF in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy prehypertensive volunteers. In addition, the study will aim to assess the impact of MOF supplementation on the exercise-induced renin-angiotensin-aldosterone system (RAAS) activation and extracellular matrix remodelling. After being informed about the study and potential risks all volunteers signing informed consent form will undergo screening to determine eligibility for the study. Eligible subjects will be randomized in the double-blind manner to monomeric and oligomeric flavanols /placebo or placebo/monomeric and oligomeric flavanols sequence (cross-over design) in a 1:1 ratio. Monomeric and oligomeric flavanols are derived from grape seeds extract and will be administered in a dose 200 mg per day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy men and women with normal to high-normal resting BP (SBP 120 - 139 mm Hg and DBP 80 - 89 mm Hg).

2. Age 35 - 65 years

3. BMI 20 - 32 kg/m^2

4. Hypertensive response to maximal exercise test defined as SBP = 200 mm Hg (men) and = 180 mm Hg (women).

Exclusion Criteria:

1. Active engagement in the weight loss programs, also including slimming diets.

2. Active smoking or abstinence from smoking for less than one year.

3. Use of medications that reduce BP and/or can potentially influence other study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc).

4. Intake of polyphenol-containing supplements for two month before and during the whole course of the study.

5. History of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study.

6. Intense sporting (>10 h/week) and/or participation in the competition at the professional level.

7. Pregnancy or breastfeeding.

8. Participation in a clinical trial within 4 weeks prior to inclusion into this study.

9. Vaccination against Covid-19 within two months before the screening/randomization visit or expected vaccination against Covid-19 during the study

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Monomeric and oligomeric flavanols
Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.

Other:
• Placebo
Placebo capsuled will be used as a comparator.

Locations

Country	Name	City	State
Netherlands	VieCuri Medical Center	Venlo	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Campus Venlo, CEP Group Holding B.V., VieCuri Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure from before to peak value during the submaximal exercise test	Excessive increase in systolic blood pressure during exercise is a well-characterized risk-factor of cardiovascular disease and is related to signs of sub clinical endothelial dysfunction.	Day 28±3, Day 84±3
Primary	Change in mean blood pressure from before to peak value during the submaximal exercise test	Increase in mean blood pressure during exercise is related to signs of endothelial dysfunction.	Day 28±3, Day 84±3
Secondary	Carotid-femoral pulse wave velocity	Carotid-femoral pulse wave velocity reflects arterial stiffness and is related to the cardiovascular risk.	Day 28±3, Day 84±3
Secondary	Biomarkers of RAAS activation	Renin, angiotensin II and aldosterone are involved in regulation of blood pressure response also during exercise.	Day 28±3, Day 84±3
Secondary	Biomarkers of inflammation	High-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, tumor necrosis factor-alpha (TNFalpha) are well-recognized molecules that characterize inflammation.	Day 28±3, Day 84±3
Secondary	Biomarkers of oxidative stress	Malondialdehyde (MDA), trolox equivalent antioxidant capacity (TEAC) reflect the activity lipid peroxidation and antioxidant defense and therefore are indicative about the condition of redox homeostasis.	Day 28±3, Day 84±3
Secondary	Biomarkers of endothelial function	Endothelin 1 and levels of nitrate/nitrite are commonly used to assess endothelial function and characterize balance between vasodilation and vasoconstriction.	Day 28±3, Day 84±3
Secondary	Biomarkers of vascular remodelling	Metalloproteinase (MMP)-9, MMP-2, tissue inhibitor of metalloproteinase (TIMP)-1, TIMP-4 are involved in modulation of extracellular matrix and their activity have been linked to vascular health.	Day 28±3, Day 84±3
Secondary	Other hemodynamic parameters	Values of systolic and diastolic blood pressure and heart rate at rest and during exercise recovery are indicators of cardiovascular risk and were related also to hemodynamic response during peak exercise.	Day 28±3, Day 84±3